Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
SANIS HEALTH INC
M05BA07
RISEDRONIC ACID
150MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0135301005; AHFS:
APPROVED
2022-06-28
_RISEDRONATE (Risedronate Sodium tablets) _ _ _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RISEDRONATE Risedronate Sodium Tablets Tablets, 150 mg risedronate sodium (as risedronate sodium hemi-pentahydrate), Oral USP Bisphosphonates (ATC Code: M05BA07) Sanis Health Inc. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Date of Initial Authorization: JUN 28, 2022 Date of revision: SEP 19, 2023 Submission Control Number: 278754 _RISEDRONATE (Risedronate Sodium tablets) _ _ _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ..................................................................................................................... 4 1.2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ........................................................... 5 4.4 Administration ........................................................... Izlasiet visu dokumentu